MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CDDRA500Q

Device Problems Wireless Communication Problem (3283); Interrogation Problem (4017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient presented remotely.Upon review, the remote monitoring application could not connect with the implantable cardioverter defibrillator (icd) due to a bluetooth telemetry anomaly on the icd.No intervention was performed.The patient experienced no adverse consequences.

Event Description

New information received notes that the implantable cardioverter defibrillator entered telemetry lockout.Programming changes were made to re-enable telemetry.The patient was in stable condition.

Manufacturer Narrative

Analysis of session records confirmed the event of telemetry anomaly on the device.A series of unsuccessful connection attempts then led to telemetry lockout.The cause of the unsuccessful attempts was undetermined.

• Brand Name: GALLANT DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 12362082
• MDR Text Key: 267952776
• Report Number: 2017865-2021-28927
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: 05415067032003
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: CDDRA500Q
• Device Catalogue Number: CDDRA500Q
• Device Lot Number: S000080440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 10/05/2021
• Supplement Dates FDA Received: 10/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1